Computer System Validation Specialist

Computer system validation specialists apply GxP compliance and testing expertise at Alimentiv, supporting reliable GCP-regulated systems with IT and Quality teams.As a Computer System Validation Specialist, you will lead validation from planning through execution. The work covers validation documentation, requirements testing, defect management, and change management. You will support compliant solutions across a global CRO focused on gastrointestinal diseases.Key Responsibilities:
Execute computerized system validation under GxP and 21 CFR Part 11Develop plans, scripts, traceability matrices, and summary reportsCoordinate testing with IT, Quality, stakeholders, and vendorsTrack defects, deviations, incidents, resolutions, and closure documentationTrain teams on validation procedures, tools, and documentation standardsRequirements:
Bachelor's degree or equivalent education and experienceThree to five years of relevant experienceExperience validating GCP-regulated systems in regulated industriesUnderstanding of validation, change control, training, and audit readinessStrong communication and cross-functional collaboration skillsBring validation documentation, testing coordination, and regulatory knowledge to strengthen system quality and compliance at Alimentiv.
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